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Active, Not Recruiting

NCT Number: NCT06832579

SmartWatch-driven AF Detection in Stroke Patients

Unrecognized atrial fibrillation (AF) is a common cause of ischemic stroke. Implantable event monitors (ICM) are the gold standard for continuous heart rhythm monitoring but they have been implemented in very few patients after stroke due to high invasiveness and high costs.

In this trial, patients with implanted ICMs (Medtronic Reveal LINQ Insertable Cardiac Monitor) will be randomized to use one of two wearables (1:1 Apple Watch or PulseOn) for continuous monitoring. The aim is to compare the probability of detecting an episode of AF with a wearable versus the gold standard ICM.

Both groups will use the wearable for 12 weeks. If the wearables detect an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed. ECG data will be transferred regularly to the CoreLab (Universityhospital Leipzig) for analysis.

After 12 weeks, the patients will visit the site and answer questions regarding the usability, compliance and satisfaction with the wearables.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders ECG Monitoring Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Secondary Prevention Stroke Vascular Diseases Wearables

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RHÖN-KLINIKUM Campus Bad Neustadt Von-Guttenberg-Straße 11 Akutneurologie II - Stroke Unit - klinische Forschung, Bad Neustadt an der Saale, Germany

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About this study

Patients with established continuous ICM monitoring from the prospective, randomized, multicenter study Find-AF 2 (NCT04371055) are recruited for this trial. Find-AF 2 is being carried out at Leipzig University Hospital since 2020 with the help of about 50 study centers throughout Germany.

The AppleWatch Series 10, a device from the current market leader, was chosen because extensive data from clinical trials is already available and data regarding the market leader has particular societal relevance. The AF detection algorithm is based on photoplethysmography (analysis of the pulse current curve) and semicontinuous monitoring. If a rhythm irregularity is detected during hourly measurements, the measurement interval is shortened. If this finding is confirmed in several consecutive measurements, the user is notified. In this pilot study, patients are trained to record a 30-second ECG with the AppleWatch in the event of notification. This is done by placing the other hand on the crown of the watch. The report will then be transmitted. The AppleWatch must be paired with another Apple device (e.g. iPhone) to use the ECG app and must be charged daily (battery life 18 hours). Our patients are provided with an iPhone for study use and are trained in using the AppleWatch.

The AppleWatch is not certified as medical device, but the ECG data collected by the AppleWatch will be used for research purposes only and not for therapeutical or diagnostical purposes.

The second wearable will be the PulseOn device. The battery lasts over two weeks. No additional device is needed for writing an ECG. AF screening is also performed photoplethysmographically. In the case of detection of an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed for registration. Regular data transfer is done at the patient's home via a gateway device to the PulseOn server. The Core lab will monitor the data transmission. Although PulseOn is a certified medical device, the ECG data collected by the PulseOn device will be used for research purposes only and not for therapeutical or diagnostical purposes. The ICM is the gold standard for recording relevant arrhythmias.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Study participation in Find-AF 2
  • Randomization in the intervention arm of the Find-AF 2 study and presence of an implanted event recorder (Medtronic Reveal LINQTM Insertable Cardiac Monitor)
  • Signed informed consent
  • All inclusion criteria of the Find-AF 2 study are met (according to protocol version Final 4.0, dated 08.05.2024):

i. Recent symptomatic ischemic stroke within the last 30 days (sudden focal neurologic deficit lasting > 24 h consistent with the territory of a cerebral artery) If the neurologic deficit lasted < 24 h a corresponding lesion* on brain imaging is needed.

ii. Age ≥ 60 years. iii. Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symtoms.

iv. Written informed consent

  • Corresponding lesion can be an acute lesion on diffusion-weighted magnetic resonance imaging, native computed tomography (CT) or CT perfusion imaging or a recent occlusion or intracranial thrombus on angiography (CTA, MRA, DSA)

Exclusion criteria

  • Expiration of the battery of the event recorder in <3 months
  • No in ICM data transmission possible (e. g. missing compliance)
  • Poor ECG data quality according to core lab evaluation (e.g. permanent oversensing), which prevents meaningful evaluation of the event recorder data
  • Exclusion criteria of the Find-AF 2 study (according to protocol version Final 4.0, dated 08.05.2024):

i. Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.

ii. Current indication or contraindication for oral anticoagulation at randomisation.

iii. Intracerebral bleeding in medical history iv. Patient scheduled for ECG-monitoring lasting > 7 days (Holter-ECG, implanted loop recorder, etc.).

v. Implanted pacemaker device or cardioverter/defibrillator or implanted cardiac monitor.

vi. Patient not willing to be treated with oral anticoagulants vii. Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.

viii. History of carotid endarterectomy or percutaneous stent intervention of cerebral or cervical artery within the last 30 days.

ix. Life expectancy <1 year for reasons other than stroke (e.g. metastatic cancer).

x. Patients under legal supervision or guardianship xi. Psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties, ... ) or participate in the required tests xii. Participation in other randomized interventional trials xiii. Suspected lack of compliance

Treatment and study plan

Wearable

Device

semi-continuous heart rhythm monitoring with Wearable

Primary outcomes

  1. sensitivity as a function of AF duration

    Time frame: from the date of device handover to the date of device return

    the probability that an AF episode will be detected as it depends on the duration of the episode

Secondary outcomes

  1. Time worn

    Time frame: from the date of device handover to the date of device return

    the proportion of time that the wearable collected and transferred data

  2. Detection sensitivity as a function of AF duration

    Time frame: from the date of device handover to the date of device return

    If the device is being worn during at least 120 seconds of an AF episode, what is the probability of its informing the patient of an arrhythmia?

  3. ECG compliance

    Time frame: from the date of device handover to the date of device return

    if the wearable informs of an episode, what is the probability that the patient will let the device save an ECG

  4. Overall sensitivity

    Time frame: from the date of device handover to the date of device return

    For patients who had at least one AF episode, what is the probability that the wearable claims there was at least one episode?

  5. Time to first ECG-confirmed AF episode

    Time frame: from the date of device handover to the date of device return

  6. Overall specificity

    Time frame: from the date of device handover to the date of device return

    for patients who had no AF episodes, what is the probability that there is no ECG confirmation of any episodes?

  7. False discovery rate (1-PPV (positive predictive value)

    Time frame: from the date of device handover to the date of device return

    For every ECG-confirmed episode found by the wearable, the gold standard episode definition will be used for comparison

  8. For the ICM: What proportion of detected signals are available as ECGs?

    Time frame: from the date of device handover to the date of device return

  9. For the ICM: What is the false discovery rate of the available ECGs?

    Time frame: from the date of device handover to the date of device return

  10. Do patients with an ICM claim to be willing to be randomized to an ICM vs a wearable?

    Time frame: after 12 weeks

  11. Patient satisfaction with the wearable

    Time frame: after 12 weeks

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Pilot Study for SmartWatch-driven AF Detection in Stroke Patients

Acronym: Find-AF2 Watch

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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